On May 13, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the first quarter ended March 31, 2021 and provided an update on recent business events (Press release, CorMedix, MAY 13, 2021, View Source [SID1234580200]).

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Recent Business Highlights:

CorMedix announced the appointment of Tom Nusbickel as the Company’s Executive Vice President and Chief Commercial Officer.
CorMedix successfully completed the agreed upon protocol for the manual extraction study identified in the Complete Response Letter that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials.
CorMedix continues to focus our efforts on resolving the deficiencies sent to the third-party manufacturer in the Post-Application Action Letter. Based on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA.
CorMedix strengthened its balance sheet via equity financing activity during the first quarter, raising net proceeds of approximately $41.5 million.
CorMedix has been approved by the New Jersey Economic Development Authority (NJEDA) to transfer substantially all of the $1.3 million of its available tax benefits to an unrelated, profitable New Jersey corporation pursuant to the New Jersey Technology Business Tax Certificate Transfer (NOL) program for State Fiscal Year 2020, for approximately $1.3 million in net proceeds. Closing is anticipated in 2Q of 2021.
Khoso Baluch, CorMedix CEO commented, "As we continue to work through the items required by FDA for resubmission of the NDA, we remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right team and resources to accomplish this as we advance DefenCath through the regulatory approval process."

First Quarter 2021 Financial Highlights

For the first quarter of 2021, CorMedix recorded a net loss of $7.2 million, or $0.20 per share, compared with a net loss of $5.6 million, or $0.21 per share, in the first quarter of 2020, an increase of $1.6 million, driven by an increase in operating expenses.

Operating expenses in the first quarter 2021 were $7.2 million, compared with $5.6 million in the first quarter of 2020, an increase of approximately 29%. The increase was driven by higher SG&A, which rose by 45% to $4.6 million, primarily due to increased non-cash charges for stock compensation, increased costs related to market research in preparation for the potential approval of DefenCath and higher staffing costs due to additional hires. R&D expense increased approximately 7% to $2.6 million, driven primarily by increases in personnel expenses and non-cash charges for stock compensation, offset by a decrease in manufacturing costs and clinical trial expenses.

The Company reported cash and short-term investments of $81.2 million at March 31, 2021, excluding restricted cash. The Company believes that, based on its current cash resources, it has sufficient resources to fund operations at least into the second half of 2022.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 13, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Following the live webcast, an archived version will be available for approximately 30 days on the Company’s website, www.cormedix.com.

On May 13, 2021 MediciNova, Inc., (Nasdaq: MNOV, JASDAQ:4875), a biopharmaceutical company developing small-molecule therapeutics, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, MediciNova, MAY 13, 2021, View Source [SID1234580046]).

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"As a late-stage biotech company with two anti-inflammatory platform candidates in development, our main focus over 2021 is execution across our programs that will enable us to not only showcase their therapeutic potential but bring us closer to delivering much-needed treatment options to patients," commented Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova. "We know from the prior approval in Japan and subsequent treatment in post-stroke dizziness and asthma that our lead product candidate MN-166 is remarkably safe and well-tolerated. We are now working to demonstrate the potential of MN-166, along with MN-001, to drive therapeutic benefit across a range of neurodegenerative, inflammatory, and fibrotic indications, without compromising immunity. Recent among these expansions has been our work in acute respiratory distress syndrome to combat the high rates of hospitalization due to COVID-19, and we are pleased to have partnered with BARDA to further evaluate MN-166 against chlorine gas-induced lung damage. MN-166 is the first candidate to have received BARDA funding under the Division of Research, Innovation, and Ventures’ (DRIVe) Repurposing Drugs in Response to Chemical Threats (ReDIRECT) program, exemplifying its differentiated potential as a safe and well-established anti-inflammatory drug."

Recent Clinical Highlights

MN-166 (ibudilast)

Formed partnership with BARDA to develop MN-166 as treatment for ARDS and ALI: In March 2021, the Company entered into a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to develop MN-166 as a potential treatment for chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Under the partnership, BARDA will provide funding for proof-of-concept studies of MN-166. The Company also continues to enroll patients in its Phase 2 clinical trial evaluating MN-166 (ibudilast) in COVID-19 patients at risk of developing ARDS. The Phase 2 trial is a randomized, double-blind parallel group study to evaluate the efficacy and safety of MN-166 in hospitalized COVID-19 patients receiving standard of care who are at risk of developing ARDS.
Continued enrollment of Phase 3 trial in ALS: The Company continues to enroll patients in its Phase 3 clinical trial evaluating MN-166 for the treatment of amyotrophic lateral sclerosis (ALS). The Phase 3 trial is a multi-center randomized, double-blind study to evaluate the efficacy, safety, and tolerability of MN-166 in ALS patients for 12 months of treatment followed by a 6-month open-label extension phase, and the primary endpoint is change from baseline in ALSFRS-R score at month 12 and survival time. Progression into this study follows positive Phase 2 data that demonstrated MN-166 resulted in a higher rate of responders on the ALSFRS-R score, indicating less functional decline compared to the placebo group. The ALSFRS-R responders showed increased overall survival compared to non-responders and MN-166 also demonstrated a favorable safety and tolerability profile.
Partnering process ongoing for progressive MS program: The Company is engaged in a process with potential partners regarding MN-166 that could lead to funding for a Phase 3 trial in progressive multiple sclerosis (PMS). In the Phase 2b trial in PMS, MN-166 achieved both primary endpoints, demonstrating a significant 48% reduction in the rate of progression of whole brain atrophy (p=0.04) as well as a favorable safety and tolerability profile. MN-166 also showed a trend of reduced risk of confirmed disability progression, an approvable endpoint for PMS, especially among secondary progressive MS (SPMS) patients without relapse, a subgroup that represents the highest unmet need with no approved long-term treatment options and accounting for approximately 80% of all SPMS patients. Based on this encouraging data and discussions with FDA, the Phase 3 trial plan is to enroll SPMS patients without relapse with 3-month confirmed disability progression as the primary endpoint.
MN-001 (tipelukast)

Completed enrollment of Phase 2 trial in IPF: The Company has completed enrollment in its Phase 2 trial of MN-001 in idiopathic pulmonary fibrosis (IPF). The Phase 2 randomized, placebo-controlled, double-blind trial is evaluating the efficacy and safety of MN-001 in patients with IPF over the course of a 26-week treatment period followed by at 26-week open label extension. The co-primary endpoints of the trial are change from baseline of forced vital capacity (FVC) and semiannual rate of decline of disease activity based on FVC.
Preparing second Phase 2 trial in NASH: Following the early completion of its Phase 2 trial evaluating MN-001 in nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) due to positive interim data, the Company is now preparing to initiate a larger Phase 2 trial in NASH. In the first Phase 2 trial, MN-001 demonstrated a statistically significant reduction in the primary endpoint, mean serum triglycerides (p=.02). The Company will provide an update on this program as the new trial is initiated.
Recent Business Updates

Established MedACT (MediciNova Ancillary Clinical Trial Support): As part of its ongoing patient support and engagement, the Company has established MedACT, a patient support program that grants financial and other support as needed across its ongoing clinical trials.
Received $4 million in gene therapy milestone payments: In April 2021, the Company announced it received two milestone payments under its agreement with Genzyme Corporation, a subsidiary of Sanofi, as a result of the successful achievement of two clinical development milestones for a gene therapy product based on adeno-associated virus (AAV) vector technology.
Discontinued development of COVID-19 vaccine: In March 2021, the Company announced its plans to discontinue development of a SARS-CoV-2 vaccine for COVID-19 to focus its resources on its later-stage development programs with larger unmet medical needs and market opportunities.
Raised $20 million through private placement: In January 2021, the Company raised $20 million through a private placement of common stock sold to 3D Opportunity Master Fund, a fund managed by 3D Investment Partners Pte. Ltd.
First Quarter 2021 Financial Results

Cash Position: As of March 31, 2021, cash and cash equivalents were $76.3 million, as compared to cash and cash equivalents of $61.3 million as of March 31, 2020. This increase was primarily due to approximately $20 million received in a private placement transaction which closed in January 2021. The Company expects current cash and cash equivalent to fund operations at least through the end of 2022.
Revenues: Revenues were $4.0 million for the three months ended March 31, 2021, compared to $0.0 million for the three months ended March 31, 2020. The $4.0 million increase was due to the receipt of two milestone payments under MediciNova’s assignment agreement with Genzyme Corporation, a subsidiary of Sanofi.
Research, Development and Patents Expenses: R&D and patents expenses were $2.1 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $0.8 million was primarily due to higher clinical trial expenses from the ongoing clinical trial of MN-166 (ibudilast) in ALS and higher stock compensation expense resulting from an increase in our stock price.
General and Administrative Expenses: G&A expenses were $2.1 million for the three months ended March 31, 2021, compared to $1.7 million for the three months ended March 31, 2020. The increase of $0.4 million was primarily due to higher stock compensation expense resulting from an increase in our stock price.
Net Loss: Net loss was $0.2 million for the three months ended March 31, 2021, or $(0.00) per basic and diluted share, as compared to a net loss of $2.7 million for the three months ended March 31, 2020, or $(0.06) per basic and diluted share.

On May 13, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported first quarter 2021 financial results and provided an update on recent progress (Press release, Checkmate Pharmaceuticals, MAY 13, 2021, View Source [SID1234580045]).

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"Since the start of 2021, we have initiated patient dosing in our core clinical trials evaluating vidutolimod (CMP-001) in combination with PD-1 blockade in melanoma and head and neck cancer. We are pleased to have also recently announced our intention to broaden our vidutolimod clinical development program into non-melanoma skin cancers in combination with Libtayo (cemiplimab), under a collaboration agreement with Regeneron," said Barry Labinger, President and Chief Executive Officer of Checkmate.

Recent Progress

Vidutolimod Clinical Updates

Year to date, Checkmate has initiated patient dosing across all three of our core clinical trials evaluating vidutolimod.
A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma.
A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma. Both melanoma trials are supported by a clinical collaboration with Bristol Myers Squibb.
A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer. Initial data in a subset of patients are expected before the end of 2021.
New translational data were presented from our Phase 1b trial of vidutolimod in combination with pembrolizumab in patients with melanoma refractory to PD-1 blockade at the 2021 American Association for Cancer (AACR) (Free AACR Whitepaper) Annual Meeting.
Collaboration and New Indication Expansion

In May, Checkmate announced the planned expansion of the development program for vidutolimod into non-melanoma skin cancers supported by a clinical supply agreement with Regeneron to evaluate the combination of vidutolimod and Libtayo (cemiplimab). The companies will collaborate on a Phase 2, proof of concept, multi-indication trial with patient cohorts in anti-PD-1 naïve and anti-PD-1 refractory cutaneous squamous cell carcinoma and anti-PD-1 refractory Merkel cell carcinoma.
First Quarter 2021 Financial Results

Research and development expenses (R&D): R&D expenses for the first quarter of 2021 were $10.4 million, compared to $6.3 million for the same period in the prior year. This increase reflected a milestone payment of $2.0 million in the first quarter of 2021 triggered by initiation of patient dosing in our Phase 2, first-line melanoma trial, as well as increases in personnel and operating expense for the planning and initiation of additional clinical trials with vidutolimod.
General and administration expenses (G&A): G&A expenses for the first quarter of 2021 were $3.8 million, compared to $1.5 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense incurred in connection with Checkmate operating as a publicly traded company.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $111.5 million as of March 31, 2021.

On May 13, 2021 IntelGenx Technologies Corp. (TSX V:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the first quarter ended March 31, 2021. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise (Press release, IntelGenx, MAY 13, 2021, View Source [SID1234580044]).

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2021 First Quarter Financial Summary:

Revenue was $286,000, compared to $202,000 in the 2020 first quarter.
Net comprehensive loss was $2.3 million, compared to 2.9 million in Q1-2020.
Adjusted EBITDA loss was $1.7 million, compared to $1.9 million in the 2020 first quarter.
First Quarter and Recent Developments:

Entered into a second feasibility agreement with ATAI Life Sciences AG ("atai") for the development of novel formulations of Salvinorin A, a naturally occurring psychedelic compound being developed for the treatment of treatment-resistant depression and other indications based on IntelGenx’s polymeric film technologies.
Completed the first shipment, consisting of 75,000 CBD Filmstrips, to Heritage Cannabis Holdings Corp. (CSE:CANN).
Announced a strategic partnership with atai, including a proposed equity investment in IntelGenx by atai. The Company’s wholly owned subsidiary, IntelGenx Corp., also received a $2.0 million secured loan from atai, of which $636,000 was used to fully repay the Company’s outstanding credit facilities with the Bank of Montreal. Subsequent to quarter-end, IntelGenx Corp. receive a second secured loan of $500,000 from atai.
Received a Notice of Allowance for US Patent Application 16/110.737, entitled "Film Dosage Form with Extended Release Mucoadhesive Particle," covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol (THC), which protects its DisinteQTM products.
Filed a new provisional patent application at the United States Patent and Trademark Office entitled "High Loading Oral Film Formulation," which covers the incorporation of high concentrations of active ingredients in products based on its VetaFilm proprietary veterinary oral film technology.
Announced the appointment of Mr. Tommy Kenny as Vice President, Intellectual Property and Legal Affairs, General Counsel of IntelGenx Corp.
"We would like to take this opportunity to thank our shareholders for their support of our transformative strategic partnership with atai, demonstrated by the approval of all related proposals at our Annual Meeting held earlier this week," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "This transaction positions IntelGenx as a leader within the novel therapeutics field of psychedelics and also provides us with the financial resources needed to continue to advance our robust portfolio of other innovative pharmaceutical film product candidates towards commercialization. We look forward to updating investors as we progress."

The atai partnership and investment are subject to the approval of the TSX Venture Exchange, in addition to certain customary closing conditions. The transaction is expected to close on or about March 14, 2021.

Financial Results:

Total revenues for the three-month period ended March 31, 2021 amounted to $286,000, an increase of $84,000, or 42%, compared to $202,000 for the three-month period ended March 31, 2020. The change is mainly attributable to an increase in product revenues of $160,000, partially offset by a decrease in research and development ("R&D") revenues of $76,000.

Operating costs and expenses were $2.2 million for the first quarter of 2021, versus $2.4 million for the corresponding three-month period of 2020. The decrease for the three-month period ended March 31, 2021 is mainly attributable to a $379,000 decrease in R&D expenses, partially offset by a $143,000 increase in manufacturing expenses, an $83,000 increase in selling, general and administrative expenses, and an increase of $13,000 in depreciation of tangible assets.

For the first quarter of 2021, the Company had an operating loss of $1.9 million, compared to an operating loss of $2.2 million for the comparable period of 2020.

Net comprehensive loss for the three-month period ended March 31 2021 was $2.3 million, or $0.02 per basic and diluted share, compared to net comprehensive loss of $2.9 million, or $0.03 per basic and diluted share, for the comparable period of 2020.

As at March 31, 2021, the Company’s cash and short-term investments totalled $2.0 million, which did not include the $500,000 secured loan granted to IntelGenx Corp. by atai in May 2021.

Conference Call Details:

IntelGenx will host a conference call to discuss these first quarter 2021 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 876-9176 (Canada and the United States) and (785) 424-1670 (International). The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On May 13, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported first quarter 2021 results and provided a corporate update (Press release, aTyr Pharma, MAY 13, 2021, View Source [SID1234580043]).

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"During the first quarter, we remained focused on advancing our lead therapeutic candidate, ATYR1923. We are tracking towards the readout from our Phase 1b/2a proof-of-concept study in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication, which is expected in the third quarter of this year," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We have key mechanistic insights regarding ATYR1923’s anti-inflammatory effects in patients from our Phase 2 study in COVID-19 related respiratory complications. This clinical data is consistent with what we have seen preclinically for key anti-inflammatory cytokines that are implicated in sarcoidosis and other ILD."

"Furthermore, we generated additional preclinical data for ATYR2810, our lead anti-Neuropilin-2 (NRP2) antibody and IND candidate, including research presented at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating tumor inhibitory effects in triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC), as both a single agent and in combination with chemotherapy and the targeted agent bevacizumab. Our manufacturing agreement with Lonza for the production of this antibody reflects our commitment to this program. We are off to a strong start in 2021 and look forward to building upon this progress throughout the year."

First Quarter 2021 and Subsequent Period Highlights

Progressed its Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. Data is expected in the third quarter of this year.

Reported positive results from its Phase 2 study of ATYR1923 in COVID-19 patients with severe respiratory complications, which provided proof-of-mechanism for ATYR1923. The study met its primary safety endpoint and demonstrated signals of clinical activity. Biomarker data showed that ATYR1923 reduced levels of several inflammatory cytokines and chemokines, including those that are implicated in sarcoidosis and other ILD, which is consistent with findings from animal models.

Appointed leading sarcoidosis advocate Andrea Wilson as a patient advisor to the company. Ms. Wilson, Co-Founder and former member of the Board of Directors for the Foundation for Sarcoidosis Research (FSR), will advise the company on patient strategies related to its clinical program for ATYR1923 in pulmonary sarcoidosis.

Participated in a Virtual Town Hall on Steroids and Sarcoidosis in collaboration with the FSR to discuss the burden of steroid treatment for patients with sarcoidosis and the need for new treatments.

Presented two posters at the AACR (Free AACR Whitepaper) Annual Meeting related to preclinical research for ATYR2810 in conjunction with the company’s scientific advisor Dr. Arthur Mercurio and his lab at the Department of Molecular, Cell and Cancer Biology at the University of Massachusetts Medical School. In models of TNBC, ATYR2810 administered in combination with widely used anti-cancer therapeutics, including chemotherapy or the targeted VEGF antibody bevacizumab, increased the anti-tumor effects of each agent. ATYR2810 also down-regulated epithelial-mesenchymal transition genes, which may be a mechanism that mediates its anti-tumor effects. In animal models of NSCLC, ATYR2810 inhibited tumor growth when administered both as a single agent and in combination with chemotherapy.

Entered into an agreement with Lonza, a leading contract development and manufacturing organization, for the manufacture of ATYR2810 to support the progression of ATYR2810 to clinical stage development.

Pangu BioPharma, the company’s Hong Kong subsidiary, together with the Hong Kong University of Science and Technology, achieved the milestones of the first year of a two-year project funded in part by the Hong Kong Government’s Innovation and Technology Commission to develop a high-throughput platform for the development of bispecific antibodies targeting NRP2.

Promoted Leslie Nangle, Ph.D., to Vice President, Research. Dr. Nangle will serve as a member of the company’s executive leadership team, managing research and scientific operations.
First Quarter 2021 Financial Results

Total revenues were $0 and $8.1 million for the three months ended March 31, 2021 and 2020, respectively. Revenues for the three months ended March 31, 2020 consisted primarily of license and collaboration agreement revenues under company’s license agreement with Kyorin. Research and development expenses were $4.5 million and $3.6 million for the three months ended March 31, 2021 and 2020, respectively. The increase was due primarily to manufacturing costs related to ATYR1923, increased research and development expenses related to ATYR2810 and increased expenses related to the research program between Pangu BioPharma, Hong Kong University and the Government of the Hong Kong Special Administration Region. General and administrative expenses were consistent between periods at $2.7 million and $2.6 million for the three months ended March 31, 2021 and 2020, respectively.

During the first quarter of 2021, the company raised gross proceeds of $9.9 million through its at-the-market offering program with H.C. Wainwright & Co., LLC and $15.3 million through its common stock purchase agreement with Aspire Capital Fund, LLC. As of March 31, 2021, aTyr had $50.6 million in cash, cash equivalents and investments.

The company expects its expenses to continue to increase in 2021 as research and development of ATYR1923 and ATYR2810 progress.

Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 6867948. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung disease. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr recently completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study was a randomized, double blind, placebo-controlled study that was designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.